Clinical Efficacy and Safety of NKT Cell Infusion in Patients With Advanced Solid Tumor

Inclusion Criteria:

* Age: 18 to 75 years, Male or Female
* Histological or cytologically diagnosis of advanced non-small cell lung cancer, or advanced gastric cancer, or advanced hepatocellular carcinoma, or advanced colorectal cancer
* Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
* Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧11.0 g/dL, Neutrophils count≧1.5×l09/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧80×l09/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
* No dyspnea at rest. Oxygen saturation ≥90% on room air
* Able to tolerate apheresis procedure including placement of temporary apheresis catheter
* No genetic disease
* No chemotherapy and radiation therapy to be planned recently
* Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
* Patients must have a Karnofsky performance status greater than or equal to 80%
* Life expectancy greater than twelve months
* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
* Agree that progress of the disease must be radiographically measurable by computerized tomography (CT) scanning technique or magnetic resonance imaging (MRI) (per RECIST1.1 criteria)
* Agrees to participate in long-term follow-up for up to 3 years, if received NKT infusion

Exclusion Criteria:

* Organ dysfunction defined as follows: Significant cardiovascular disease (i.e. New York Heart Association \[NYHA\] class 3 congestive heart failure, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness
* Suffering from lymphoma or leukemia
* Serious infections requiring antibiotics, bleeding disorders
* Patients with myelodysplastic syndrome (MDS)
* History of immunodeficiency disease or autoimmune disease
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Known central nervous system tumors including metastatic brain disease, unless treated and stable
* Other malignancy within 3 years prior to entry into the study
* Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
* Patients with chronic disease which is undergoing immune reagents or hormone therapy
* Previous bone marrow or stem cell transplant, or organ allograft
* Within concurrent chemotherapy
* Concomitant treatment with corticosteroids (Topical or inhalational corticosteroids are permitted)
* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
* Pregnant or breast-feeding patients
* Mental impairment or addictive disorders that may compromise the ability to give informed consent
* Lack of availability of a patient for immunological and clinical follow-up assessment